FDA Food Safety Modernization Act Registration

[jim lyon]

I don't know, there is a lot of stuff in there to digest. It may not be as simple as you are hoping. I did notice this:

[sbull] The definition of farm now includes facilities that pack or
hold food, provided that all food used in such activities is grown,raised, or consumed on that farm or another farm under the sameownership;

[wildbranch2007]

I couldn't let this rest.
Click on the more information under food facility registration which brought me to the following:
http://www.fda.gov/Food/FoodDefense/...81637.htm#IIId


Which within clearly states FARMS are exempt.

Sounds like I am legally NOT required to register.

the problem I have with all the information that I find and others post is
D. Comments on ``Who is Exempt From This Subpart?'' (Proposed Sec. <-----notice the word proposed
1.226)

In the interim final rule, the title of this section has been <--- interim final rule
changed to ``Who does not have to register under this subpart?''

The government expect you to conform to the laws/rules and you should have registered and the laws/rules haven't been written/finalized but the law has been signed by the president, I know that "things" are moving faster in real life than the government can keep up with but I originally registered 10 years ago, they have had 10 years to do something. I expect a finished version b/4 its signed, then again I don't have that high of expectations. sorta like being charged with a crime, you sign the documents and the cop says he will fill in the details later. Even better IMHO (from the thread by the same name) everyone with a honey house that I know, when I ask what they think not a one has a clue that they should have registered. now got my blood flowing will go cause some trouble.

[sqkcrk]

What is interesting to me is that instead of asking what do I need to do to conform to the Law people ask questions about how do I get around this? It is not clear as to who is eligible for exemption, but isn't it clear that EVERYONE is supposed to register and apply for exemption? Or face the possibility of getting served w/ a fine?

[wildbranch2007]

What is interesting to me is that instead of asking what do I need to do to conform to the Law people ask questions about how do I get around this? It is not clear as to who is eligible for exemption, but isn't it clear that EVERYONE is supposed to register and apply for exemption? Or face the possibility of getting served w/ a fine?

no it is not clear that everyone has to register, NO ONE I KNOW EVEN KNOWS ABOUT THE LAW, I wouldn't either if you had not brought it up!!! I realize ignorance of the law is no excuse, but take a look around as I have, you are the only one that has brought up the subject in any forum that I frequent, none of the bee organizations have any thing on there web sites, at the last minuite the nyhoney produces got someone to speak and from your previous post they couldn't/wouldn't answer the question. Nothing I lookat/find is the final bill, I haven't found anything that says what the honey house must have to comply, the parts I have read say if your state already does inspections then they will still do the inspections, so I """assu me""" that things will stay the same in N.Y. as they have also not addressed how you will get inspected if your state doesn't do inspections. IMHO you must register as someone contacted you telling you to do so, no one has contacted me so I don't feel the need to register, In one of the incomplete preliminary pieces of work that I read, the EPA stated how many facilities they expected to register, so they must know(i don't really believe this) where these facilities are, and look at the number that they used it would also be quite apparent that they don't expect small honey houses to register or the number would have been considerably larger. Most of the people I have told about the inspection process and the possible $241 dollar an hr. cost to be reinspected said and I do quote here, they will continue processing honey until the get one violation and need to get reinspected, they will break up the bees into nucs and sell them off and go on vacation. They also expect that since all of them are/have been registerd beeks in NY that the state of NY or cornell at some point might point them in the correct direction. could you post the title of the blue book referenced previously so I can see if I can find that only. thanks
I had better post or will get sent off to tailgater

[wildbranch2007]

I couldn't let this rest. I called up FDA in Maryland. They told me on the phone exemptions: Home based operations, tax code 50133 (not for profit).

So I asked for where to find our exemptions on the internet and she gave me
http://access.fda.gov

Click on the more information under food facility registration which brought me to the following:
http://www.fda.gov/Food/FoodDefense/...81637.htm#IIId


Which within clearly states FARMS are exempt.

Sounds like I am legally NOT required to register.

I called the small buisness ass. they sent me to the fda which sent me to the same link as you posted above, problem is the government doesn't know what is going on either, if you look at the top of the document, you will find that this is the old law, not the current one in affect that they are still writing

date on the law above. October 10, 2003: now I'll go beat my head against the wall and ask the epa directly, last time it took over a year for a response.

[sqkcrk]

I got a notice from ABF, that's how I first heard about it. That's when I opened thgis Thread.

www.cfsan.fda.gov

www.fda.gov/fsma

Short of mailing you a packet, that's the best I can do.

[wildbranch2007]

thanks for the links, I had allready read most of that. I have been in contact with a large commercia beek. He got to read the information that was provided to a packer that has already been inspected, I'll quote his interpretations below if my mail account will ever open. yahoo is having tech. difficulties.

he said he is inspected by county and state, so as he reads the info provided, he doesn't have to register with the fda as they already know about him. He said he has also dropped all of his commercial accounts like super markets to eliminate the hassel that he would get from keeping them. I'll update this to his own words when my email comes back.

[sqkcrk]

I wonder why there isn't an effort against this Food Safety Act comparable to the antiSOI effort?

[BMAC]

Maybe there is an ANTI FSMA team like the anti SOI team. Which was fairly humorous and ended up getting nothing done last week.

[wildbranch2007]

I wonder why there isn't an effort against this Food Safety Act comparable to the antiSOI effort?

had to go look up anti soi , most everybody agrees that its probably a good idea, the problem still is they are writting it as they go, there communication skills are zero, we don't mind setting up the honey house to conform, if we knew the rules, have the time during the winter, and all the excess cash from honey sales to help fund the economy but no guidance.
How can you rise up against something when you only hear about it after its been signed into law?

[BMAC]

amen to that.

The FDA rep didnt really have any valid answers at the meeting either.

[sqkcrk]

Mike, we have been talking about it, around it, passed each other about it, and all sorts of things in all sorts of ways in NY for going on 5 years now. It isn't Law yet. And probably won't be, unless Farm Bureau signs off on it, from what I have heard.

Lots of folks agree it isn't a good idea.

[sqkcrk]

amen to that.

The FDA rep didnt really have any valid answers at the meeting either.

I wish I had stayed in the room, but had to address the Wellness Workshop folks. The Rep has to be careful what she says or her job would be in jeapordy. Besides, she can't really say who can and who can't when the point is to get everyone on the rolls.

[BMAC]

I started a new SOI thread so SOI isnt confused with FSMA stuff.

[deknow]

...of course the farm exemption doesn't apply for buckets or barrels of honey bought in....and from the wording, it doesn't apply to your own honey if you do bring in honey from others. Of course, we already know that beekeepers commonly relabel this stuff as their own....

deknow

[loggermike]

So did everyone figure this thing out?

The latest from FDA:http://www.fda.gov/Food/GuidanceComp...ce=govdelivery

Clear as mud........

[honeyshack]

When we applied to be registered and set up our standards in the honeys house, in compliance with the CFIA Inspection and Registration program, one of the things that was said to me about getting the majority of beekeepers to be a registered food producing facility was so that they could tighten honey coming in from suspect countries.
It is easier to enforce standards on sub standard producing countries when the country imposing those standards meets it themselves. I agree with that concept.
Some of the changes in our honey house are a bit of a pain...ie logs, but some are really good. Food grade paint on the walls if they are not sheeted with tin or acrylic sheets. Protective covers on the light bulbs be it florescent or incandecent. And that is a good idea because if a bulb breaks, how do you find every last speck of glass or in the case of florescent, the gas, from the honey? To great of a risk for contamination. Add into it, handwashing, floor cleaning, staff training.
We provide a food product which feeds the world, our country or just our community. In reality we are no different than meat packing houses, canneries, grocers bakeries, and milk plants. If they have food standards to follow, why should we not?

[wildbranch2007]

I'm still waiting for the final version, I have never found it safe to try and hit a moving target.

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

I just love it. when they use word like "current thinking" "does not operate to bind the FDA" ya got to love it. If they wrote the constitution like they write stuff now we would all be in trouble.

[wildbranch2007]

I'm not a lawyer, what does the following mean, I never get double nots correct.

from the MSMA
1.2 Q: [Added December 2012] Has the scope of who is required to register under section 415 of the FD&C Act changed?

A: No. At this time, the same type of food facilities that were required to register with FDA under section 415 of the FD&C Act before FSMA are required to register with FDA and renew such registrations every other year. Those facilities are domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States (21 CFR 1.225). For purposes of section 415, the term “facility” in relevant part does not include farms, restaurants, and retail food establishments (section 415(c)(1) of the FD&C Act; 21 CFR 1.226). <--- "for purposes of section 415 in relevant part does not include farms or is this saying farms are not included



§ 1.226 21 CFR Ch. I (4–1–11 Edition)
§ 1.226 Who does not have to register <---- who does not have to register under this subart
under this subpart?
This subpart does not apply to the
following facilities:
(a) A foreign facility, if food from
such facility undergoes further manufacturing/
processing (including packaging)
by another facility outside the
United States. A facility is not exempt
under this provision if the further manufacturing/
processing (including packaging)
conducted by the subsequent facility
consists of adding labeling or any
similar activity of a de minimis nature;
(b) Farms; <----- This subpart does not apply to the following facilities
(c) Retail food establishments;

so do farms have to register???? I couldn't resist trying to read it. My wife says the double not means farms don't have to register and she's a higher authority than the gov. here

[BMAC]

higher authorities always prevail.